UCB Archives - Medical Design Sourcing

Core trends in 2023 FDA drug approvals: Oncology, neurology and hematology dominate

2023 was a big year for hematology, neurology and oncology, with the medical specialties seeing the most FDA approvals. In terms of sponsors, Pfizer had the most approvals with six total, followed by UCB and Chiesi, each with three apiece.

When looking at commercial prospects, AstraZeneca’s respiratory syncytial virus antibody Beyfortus could be the biggest blockbuster from the 2023 cohort with expected peak sales of $1.9 billion. Alzheimer’s drug Leqembi could also be a major success, making up for the tepid demand for Aduhelm, which won conditional approval in 2021. While Aduhelm’s sales have sputtered, Leqembi could see peak revenue of $4.8 billion according to analysts.

Oncology continues to be a hot specialty with the most competition among the newly approved drugs, as the FDA continues to green light new entrants in crowded target classes such as PD-1 inhibitors.

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ClearPoint Neuro enters drug delivery licensing deal with UCB

ClearPoint Neuro (Nasdaq:CLPT) announced today that it entered into a multi-year license agreement with UCB over gene therapy delivery.

Solana Beach, California-based ClearPoint Neuro develops a therapy-enabling platform providing navigation and delivery to the brain. The licensing agreement with UCB establishes a partnership on delivery platforms for UCB’s gene therapy portfolio.

Get the full story at our sister site, Drug Delivery Business News.

Biogen announces biosimilars collaboration deal with Xbrane

Having recently sold an equity stake in Samsung Bioepis for up to $2.3 billion, Biogen (NSDQ:BIIB) has announced a licensing deal with Xbrane Biopharma (STO:XBRANE), a Swedish biosimilar developer.

The agreement relates to the development of Xcimzane, a preclinical monoclonal antibody referencing Cimzia (certolizumab pegol) from UCB.

Having first won FDA approval in 2018 for moderate to severe Crohn’s Disease, Cimzia has a primary indication for rheumatoid arthritis in adults. The drug is also indicated for axial spondylarthrosis, psoriasis and Crohn’s disease.

Global sales of the drug were €1.8 billion in 2020.

The collaboration deal will give Biogen exclusive global rights to the drug.

“This preclinical biosimilar candidate has the potential to add another option for patients living with rheumatoid arthritis and other indications,” said Ian Henshaw, head of global biosimilars at Biogen, in a news release.

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Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)

Get the full picture from our sister site, Drug Discovery & Development.

Pharma’s top 20 R&D spenders in 2020

[Lab image by Michal Jarmoluk from Pixabay]

The past year has been an unprecedented time for the pharmaceutical industry.

On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.

While the pandemic certainly was a driver for substantial R&D spending in the industry in 2020, a significant expense for many companies last year was licensing fees and other acquisition costs. That trend is not just apparent for Incyte, which tops this list, but also for several other companies in this ranking of 20 firms, which are ranked below based on the percent of revenue they invest in R&D. (To find out the top 50 pharma companies, check out our recently published ranking here.)